MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40

ClinicalTrials ID:NCT07493538

This Phase II trial evaluates Treosulfan and Fludarabine conditioning with post-transplant Cyclophosphamide for hematological diseases. Eligible patients aged 2-75 with specific organ function criteria receive stem cell infusions from matched donors. Interventions include Treosulfan, Fludarabine, TBI, Tacrolimus, MMF, and Cyclophosphamide, focusing on GVHD prophylaxis.

Patient Parameters

Program Overview

This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.

Eligibility Criteria

Inclusion Criteria

  • Patients 2-75 years of age
  • ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (< 16 years) with appropriate organ criteria as below (in other inclusion criteria)
  • 5/6 or 6/6 related donor, OR a 5-8/8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5/10) related donor
  • adequate liver (no decompensated liver failure, Child Pugh A, AST/ALT <5X ULN) and renal function (creatinine <2.0)
  • absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
  • DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement

Exclusion Criteria

  • Pregnant or breastfeeding
  • Evidence of untreated/uncontrolled HIV infection
  • Untreated active serious infection
  • Active CNS malignancy
  • CML in blast crisis not in a complete remission by abnormal blast count.
  • Less than 3 months since prior myeloablative transplant

Locations

FACILITYZIPCITYSTATE
Masonic Cancer Center at University of Minnesota55455MinneapolisMinnesota

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